Early Mobilization After CABG Surgery

NCT ID: NCT07230561

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-01-31

Brief Summary

The goal of this clinical trial is to learn if a structured early exercise program can help patients recover better in people who have just had coronary artery bypass surgery. The main questions it aims to answer are:

• Does this early exercise improve fitness and walking ability?
• Does it reduce the risk of muscle weakness (sarcopenia) after surgery?
• Does it improve patients' quality of life?
• Does it reduce feelings of anxiety and depression? Researchers will compare the group receiving the structured early exercise program (plus standard hospital care) to the group receiving standard hospital care only to see if the early exercise program leads to better and faster recovery.

Participants in the exercise group will:

• Start supervised exercise sessions within 24 hours after their surgery.
• Perform these sessions twice a day for 30 minutes each, for 5 days.
• The exercises include warm-ups, breathing exercises, walking or stationary cycling, and light resistance training.

Conditions

Coronary Artery Disease; Coronary Artery Bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise Group

Participants received standard hospital nursing care PLUS supervised, structured early mobilization training. The protocol was developed by integrating Phase 1 cardiac rehabilitation guidelines with an expert consensus approach from a multidisciplinary team. The intervention began within 24 hours postoperatively, was conducted for 5 days, twice daily, 30 min/session. Sessions included a 5-min warm-up (active/passive ROM), a 20-min main training (FITT principle: Intensity at resting heart rate + 20 bpm, max 120 bpm; Type: inspiratory muscle training, ROM, stationary cycling or bedside ambulation, resistance training), and a 5-min cool-down.

Group Type: EXPERIMENTAL

Structured Early Mobilization Training

Intervention Type: BEHAVIORAL

The training protocol was developed by integrating Phase 1 cardiac rehabilitation guidelines with an expert consensus approach from a multidisciplinary team. The intervention began within 24 hours postoperatively, was conducted for 5 days, twice daily, 30 min/session. Sessions included a 5-min warm-up (active/passive ROM), a 20-min main training (FITT principle: Intensity at resting heart rate + 20 bpm, max 120 bpm; Type: inspiratory muscle training, ROM, stationary cycling or bedside ambulation, resistance training), and a 5-min cool-down.

Standard Hospital Nursing Care

Intervention Type: OTHER

The standard hospital nursing care included physiological monitoring, medication counseling, psychological support, disease-specific health education, instruction on the use of an incentive spirometer, and education on the importance and methods of rehabilitation.

Comparison Group

Participants received standard hospital nursing care only. This included physiological monitoring, medication counseling, psychological support, disease-specific health education, instruction on the use of an incentive spirometer, and education on the importance and methods of rehabilitation.

Group Type: ACTIVE_COMPARATOR

Standard Hospital Nursing Care

Intervention Type: OTHER

The standard hospital nursing care included physiological monitoring, medication counseling, psychological support, disease-specific health education, instruction on the use of an incentive spirometer, and education on the importance and methods of rehabilitation.

Interventions

Structured Early Mobilization Training

The training protocol was developed by integrating Phase 1 cardiac rehabilitation guidelines with an expert consensus approach from a multidisciplinary team. The intervention began within 24 hours postoperatively, was conducted for 5 days, twice daily, 30 min/session. Sessions included a 5-min warm-up (active/passive ROM), a 20-min main training (FITT principle: Intensity at resting heart rate + 20 bpm, max 120 bpm; Type: inspiratory muscle training, ROM, stationary cycling or bedside ambulation, resistance training), and a 5-min cool-down.

Intervention Type: BEHAVIORAL

Standard Hospital Nursing Care

The standard hospital nursing care included physiological monitoring, medication counseling, psychological support, disease-specific health education, instruction on the use of an incentive spirometer, and education on the importance and methods of rehabilitation.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• age between 40 and 85 years;
• undergoing first-time CABG surgery;
• no diagnosed psychiatric disorders or musculoskeletal diseases and did not require any assistive mobility devices;
• ability to communicate in Mandarin or Taiwanese;
• agreed to participate and provided written informed consent after receiving a comprehensive explanation of this trial.

Exclusion Criteria

• preoperative use of continuous 24-hour nitroglycerin infusion or inotropic agents;
• undergoing emergency cardiac surgery or requiring admission to the intensive care unit preoperatively;
• occurrence of major intraoperative complications (e.g., major hemorrhage, stroke, requirement for resuscitation, or severe delirium).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Far Eastern Memorial Hospital

OTHER

Sponsor Role: collaborator

Tri-Service General Hospital

OTHER

Sponsor Role: collaborator

Ta-Chung Chao

OTHER

Sponsor Role: lead

Responsible Party

Ta-Chung Chao

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Far Eastern Medical Foundation Far Eastern Memorial Hospital

New Taipei City, , Taiwan

Countries

Taiwan

Other Identifiers

FEMH-2024-C-094

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

113105-F

Identifier Type: -

Identifier Source: org_study_id